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2 Objective To describe the role that Health Canada plays in clinical research in Canada To provide an overview of the GCP compliance monitoring program in Canada To explain the process by which clinical trial inspections are conducted in Canada To provide a summary of findings from inspections conducted since 2002

4 Structure and Responsibilities Our Mandate: Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.

8 Structure and Responsibilities (cont d) The s primary role, in collaboration with the operational centres, is to deliver a national compliance and enforcement program for drugs, natural health products, medical devices, including biologics and genetic therapies. This includes a GCP program for the verification against and the enforcement of the regulatory framework for clinical trials involving human subjects.

13 C (Sponsor s Obligations GCP) Clinical trials regulatory framework is harmonized through the principles of good clinical practices, as described by ICH E6 Guideline for Good Clinical Practices. ICH E6 was adopted by Health Canada in ICH E6 outlines requirements for the design, conduct and recording of trials. Consistent with the Declaration of Helsinki.

14 C (Sponsor s Obligations GCP) It is the sponsor s responsibility to ensure adherence to good clinical practices, including those requirements outlined in this section. Few requirements are black and white The need for no more than one QI. ICH E6 provides interpretation. Some requirements differ from ICH E6 The duration of record retention (C ).

15 C (Sponsor s Obligations GCP) The clinical trial is scientifically sound and clearly described in a protocol; The clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division; Refer to ICH GCP sections 4.5 and Deviations from or changes to the protocol should not be done without Sponsor agreement and REB/Health Canada approval, as needed. Any deviation from the approved protocol should be documented and explained.

16 C (Sponsor s Obligations GCP) Systems and procedures that assure the quality of every aspect of the clinical trial are implemented; Refer to ICH GCP sections 5.1, 5.18 and QA and QC requirements, including:» Written SOPs to ensure compliance with the protocol, GCP, and regulatory requirements;» At a minimum, SOPs should cover informed consent process, AE reporting, handling of the drug, record retention;» Written agreements, made by the sponsor with any party(ies) involved with the clinical trial.

17 C (Sponsor s Obligations GCP) For each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site; Refer to definition of REB under C Refer to ICH GCP sections 4.4 and At each clinical trial site, there is no more than one QI; Refer to definition of QI under C

18 C (Sponsor s Obligations GCP) At each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the QI; Refer to ICH GCP sections 2.7 and 4.3. Provide adequate medical care to a subject for any AEs, including clinically significant laboratory values. Inform a subject when medical care is needed for intercurrent illness(es). Make a reasonable effort to ascertain the reason(s) for withdrawal, while fully respecting the subject's rights.

19 C (Sponsor s Obligations GCP) Each individual involved in the conduct of the clinical trial is qualified by education, training and experience; Refer to ICH GCP sections 2.8, , 4.2.4, and (b). There must be evidence of such qualifications. Includes knowledge by all trial personnel of:» the protocol, the investigational product(s) and their trialrelated duties and functions;» GCP and the applicable regulatory requirements. Includes supervision of the overall conduct of the trial, handling and verifying the data, conducting the statistical analyses, preparing the trial reports and monitoring the trial.

20 C (Sponsor s Obligations GCP) Written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of:» the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and» all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial Refer to ICH GCP sections 2.9 and 4.8.

21 C (Sponsor s Obligations GCP) The ICF must be approved, as well as any amendments; It is to be revised whenever important new information becomes available that may be relevant to the subject's consent; The subject should be informed in a timely manner if new information becomes available that may be relevant to his/her willingness to continue (to be documented); The subject should be fully informed of all pertinent aspects of the trial;

22 C (Sponsor s Obligations GCP) The language used should be as non-technical as practical and should be understandable to the subject; Time must be afforded to the subject to inquire about the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject; Prior to a subject's participation, the ICF should be signed and personally dated by the subject and by the person who conducted the informed consent discussion.

23 C (Sponsor s Obligations GCP) The subject must understand (via both the informed consent discussion and the ICF): That the trial involves research The purpose of the trial The trial treatment(s) and the probability for random assignment to each treatment The trial procedures to be followed The subject's responsibilities The alternatives that may be available to the subject, and their important potential benefits and risks

24 C (Sponsor s Obligations GCP) That their participation in the trial is voluntary and that they may refuse to participate or withdraw from the trial, at any time Who may be granted direct access to their original medical records for verification of clinical trial procedures and/or data That records identifying them will be kept confidential Whom to contact for further information The expected duration of their participation in the trial.

25 C (Sponsor s Obligations GCP) The requirements respecting information and records set out in section C are met; Refer to Guide-0068» Essential documents should be retained as per ICH E6 (REB: section 3.4, QI: section and Sponsor: section ).» The original records need to be kept for 25 years. The drug is manufactured, handled and stored in accordance with the applicable GMPs; Refer to Annex 2 to the Current Edition of the GMP Guidelines.

26 C (Labelling) The sponsor shall ensure that the drug bears a label that sets out the following information in both official languages: a statement indicating that the drug is an investigational drug to be used only by a qualified investigator the name, number or identifying mark of the drug the expiration date of the drug.

27 C (Labelling) the recommended storage conditions for the drug the lot number of the drug the name and address of the sponsor the protocol code or identification, and if the drug is a radiopharmaceutical as defined in section C , the information required by subparagraph C (1)(b)(vi).

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